TiN Coated Humeral Head

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name: TiN Coated Humeral Head FDA UDI
Generic Name: Stem-fixed metallic humeral head prosthesis FDA UDI
Device Name: OFFSET HEAD CoCr/TiN 41x16 FDA UDI
Model / Reference: 116-4100 FDA UDI
Description: OFFSET HEAD CoCr/TiN 41x16 FDA UDI

Identifiers

Catalog Number: 116-4100 FDA UDI
Primary DI / UDI-DI: 03701037300961 FDA UDI
510(k) Number: K191698 FDA UDI
FDA Product Code: PHX FDA UDI
KWT FDA UDI
GMDN Term: Stem-fixed metallic humeral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Stem-fixed metallic humeral head prosthesis

TiN Coated Humeral Head by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fx Solutions

Sources (1)

FDA UDI 5c4c3101-5d40-4d28-9bab-2c3d6b04ad64 36 fields · synced May 30, 2026